Identity
- Trade Name
- Elvie Pump Single AMZA FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- Elvie Pump - Single Electric Breast Pump - AMZA - Baked Breast pump, powered FDA UDI
- Model / Reference
- EP01-01-N4 FDA UDI
- Description
- Elvie Pump - Single Electric Breast Pump - AMZA - Baked Breast pump, powered FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060442520561 FDA UDI
- 510(k) Number
- K181863 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breast pump, electric
Elvie Pump Single AMZA by Willow Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast pump, electric.
- AMEDA® — CIMILRE CO ., LTD · Class II
- Nurture Bra — IMALAC, INC. · Class I
- Nurture Bra — IMALAC, INC. · Class I
- Nurture Bra — IMALAC, INC. · Class I
- Little Martin's Drawer — EBZNS HOLDINGS LLC · Class II
- LVB — Huizhou LVB Maternal & Infant Supplies Co., Ltd. · Class II
- Symmetrical Health, LLC — CIMILRE CO ., LTD · Class II
- Ameda, Inc. — Ameda, Inc. · Class II
Cleared under the same submission
K181863 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Willow Innovations, Inc.
Sources (1)
- FDA UDI 8fb133ad-1db2-41dd-9a3d-dc7edadac2cf 34 fields · synced Jun 1, 2026